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Spine FusionENNOVISTNCT03507881

Prospective Study on Ennovate® Pedicle Screw Fixation in Isthmic Spondylolisthesis Patients

An observational study of Spine Fusion and Isthmic Spondylolisthesis, run by Aesculap AG at 3 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The present study is planned to demonstrate the efficacy and safety of a new pedicle screw system for the specific indication of isthmic spondylolisthesis, as this condition concerns relatively young patients requiring good fixation of the performed reposition to come to satisfactory clinical results. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Spine Fusion, Isthmic Spondylolisthesis
What is being tested?
fusion
Type of treatment
Medical device
How many people
2 participants
Where
3 sitesGermany
Study dates
31 Jul 2018to 18 Jan 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: adult patients

Who may be able to join

  • Symptomatic single-level IS (L4-S1), (VAS > 30mm, treated conservatively for a minimum of 6 months)
  • Isthmic Spondylolisthesis Meyerding grade I and II
  • Signed Informed Consent of the patient regarding the participation in this study

Who cannot join

  • Multilevel IS
  • Severe degenerative changes of cranial adjacent level (disc height of <50% of the next healthy segment,
  • Previous lumbar spine surgery except microdiscectomy or micro- decompression of the index level
  • Patients psychically or mentally not able to give or refuse consent
  • Patients psychically or mentally not able to answer the questions regarding their health status and quality of life
  • Pregnancy (current or planned)
Show all 11Show fewer
  • BMI >35
  • Systemic or local infection
  • Chemotherapy or radiation ongoing
  • Desire of early retirement (running pension request)
  • All contraindications as listed in the instructions for use

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • Klinikum der J. W. Goethe-Universität, Klinik für Allgemein- und Visceralchirurgie

    Frankfurt am Main, 60590

  • Katholisches Klinikum Koblenz

    Koblenz, 56073

  • Sana Klinikum Offenbach GmbH

    Offenbach, 63069

Other trials in Germany

About this study

Official title: Prospective Study on Clinical and Radiological Results With Ennovate® Pedicle Screw Fixation in Isthmic Spondylolisthesis Patients

The present study is planned to demonstrate the efficacy and safety of a new pedicle screw system for the specific indication of isthmic spondylolisthesis, as this condition concerns relatively young patients requiring good fixation of the performed reposition to come to satisfactory clinical results.

Read the detailed description

Adult Isthmic spondylolisthesis, which is associated with "spondylolysis," is defined as an osseous discontinuity of the vertebral arch at the isthmus (the pars interarticularis), which usually occurs in the fifth lumbar vertebra. The prevalence of isthmic spondylosis is proposed to be about 6% to 26% in different studies. The European Spine Tango registry found 15%. It is proposed to affect more men than women. Conservative treatments including braces, physical therapy, and medication are shown to be effective for some patients; however, surgical treatments are mainly the final effective treatment. There are several different options for surgery among which posterolateral fusion (PLF) is considered as the method of choice. It is shown that PLF is more effective than conservative treatments such as exercise. The fusion helps to fix the motion of the affected segment and therefore, might lead to pain reduction. Decompression, supplemental instrumentation, and supplemental anterior column support are also considered for treatment. These treatment strategies can be used separately or in any combination; however, studies trying to compare separate treatments with a combination of them have led to inconsistent results.

Supplementary pedicle screws might be added to fusion methods for fixation and it is proposed that they have the ability to correct the deformity, reduce the listhesis, and increase the fusion rates, although a majority of the studies comparing instrumented PLF and noninstrumented PLF could not show the superiority of instrumented approaches. The literature has been reviewed in 2000 already, and the method has already been proved to be "practical, safe, and effective" for various spinal indications. Other authors found a better result for isthmic spondylolisthesis patients with posterior lumbar interbody Fusion (PLIF), vs. PLF, especially for high grade isthmic spondylolisthesis.

The present study is planned to demonstrate the efficacy and safety of a new pedicle screw system for the specific indication of isthmic spondylolisthesis, as this condition concerns relatively young patients requiring good fixation also in the long-term.

Being tested
fusion
Keywords
isthmic spondylolisthesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fusionDevice

    Internal fixation

Study groups in NCT03507881
Study groupRoleWhat they receive
EnnovateImplantation of an Ennovate® internal fixation
Receives: Device: fusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Leg pain

    Leg Pain measured by Visual analogue scale (VAS) after 1 year follow-up: measured by Visual Analogue Scale: The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.

    Measured: 1 year

Secondary outcomes (10)

  1. Leg Pain

    Leg Pain measured by Visual analogue scale (VAS) at all timepoints except 1 year; measured by Visual Analogue Scale: The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.

    Measured: Preoperative, 3 months, 6 months

  2. Back Pain

    Back Pain measured by Visual analogue scale (VAS) at all timepoints; measured by Visual Analogue Scale: The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.

    Measured: Preoperative, 3 months, 6 months, 1 year

  3. Functional Disability

    Measured by Oswestry Disability Index (ODI) at all timepoints; The ODI is an index derived from the Oswestry Low Back Pain Questionnaire to quantify disability for low back pain. The self-completed questionnaire contains ten Topics: intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.

    Measured: Preoperative, 3 months, 6 months, 1 year

  4. Patient satisfaction

    Patient Satisfaction with Operation Result (very high / high / medium / low / very low)

    Measured: 3 months, 6 months, 1 year

  5. Quality of Life

    Quality of Life measured by EQ-5D-5L Questionnaire: The 5-level EQ-5D version (EQ-5D-5L) was introduced by the EuroQol Group in 2009 to improve the instrument's sensitivity and to reduce ceiling effects, as compared to the EQ-5D-3L. The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety / depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

    Measured: preoperative, 3 months, 6 months, 1 year

  6. Clinical Complications

    Adverse Events (AE) and Serious Adverse Events (SAE) forms filled at all timepoints intraop and postop

    Measured: intraoperative, 3 months, 6 months, 1 year

  7. Fusion status

    Fusion assessment (acc. to Bridwell)

    Measured: 3 months, 6 months, 1 year

  8. Radiographically assessed complications

    Construct stability, loosening, implant breakage, other adverse events (Osteolysis, screw misplacement, device migration)

    Measured: 3 months, 6 months, 1 year

  9. Loss of Reduction of the Reposition [degree]

    Results regarding the maintenance of the reposition of the isthmic spondylolisthesis throughout the follow-up; loss of reduction during follow-up measured in [degree]

    Measured: 3 months, 6 months, 1 year

  10. Range of Motion

    Range of motion (angular and translational; degrees/mm)

    Measured: 3 months, 6 months, 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2018
  2. Study start31 Jul 2018
  3. Primary completion18 Jan 2019
  4. Study completion18 Jan 2019

Why it stopped: Recruitment too slow

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03507881
Sponsor's protocol ID
AAG-O-H-1619
Acronym
ENNOVIST
Status last verified
Sep 2019
First submitted
16 Apr 2018
Last updated
18 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gaines RW Jr. The use of pedicle-screw internal fixation for the operative treatment of spinal disorders. J Bone Joint Surg Am. 2000 Oct;82(10):1458-76. doi: 10.2106/00004623-200010000-00013.

    PubMed 11057475

  • Dehoux E, Fourati E, Madi K, Reddy B, Segal P. Posterolateral versus interbody fusion in isthmic spondylolisthesis: functional results in 52 cases with a minimum follow-up of 6 years. Acta Orthop Belg. 2004 Dec;70(6):578-82.

    PubMed 15669459

  • Etemadifar MR, Hadi A, Masouleh MF. Posterolateral instrumented fusion with and without transforaminal lumbar interbody fusion for the treatment of adult isthmic spondylolisthesis: A randomized clinical trial with 2-year follow-up. J Craniovertebr Junction Spine. 2016 Jan-Mar;7(1):43-9. doi: 10.4103/0974-8237.176623.

    PubMed 27041885

  • Taillard WF. Etiology of spondylolisthesis. Clin Orthop Relat Res. 1976 Jun;(117):30-9.

    PubMed 1277680

  • Kalichman L, Kim DH, Li L, Guermazi A, Berkin V, Hunter DJ. Spondylolysis and spondylolisthesis: prevalence and association with low back pain in the adult community-based population. Spine (Phila Pa 1976). 2009 Jan 15;34(2):199-205. doi: 10.1097/BRS.0b013e31818edcfd.

    PubMed 19139672

  • McTimoney CA, Micheli LJ. Current evaluation and management of spondylolysis and spondylolisthesis. Curr Sports Med Rep. 2003 Feb;2(1):41-6. doi: 10.1249/00149619-200302000-00008.

    PubMed 12831675

  • STEWART TD. [The age incidence of neural-arch defects in Alaskan natives, considered from the standpoint of etiology]. J Bone Joint Surg Am. 1953 Oct;35-A(4):937-50. No abstract available. Undetermined Language.

    PubMed 13108895

  • Osterman K, Schlenzka D, Poussa M, Seitsalo S, Virta L. Isthmic spondylolisthesis in symptomatic and asymptomatic subjects, epidemiology, and natural history with special reference to disk abnormality and mode of treatment. Clin Orthop Relat Res. 1993 Dec;(297):65-70.

    PubMed 8242953

  • Jacobs WC, Vreeling A, De Kleuver M. Fusion for low-grade adult isthmic spondylolisthesis: a systematic review of the literature. Eur Spine J. 2006 Apr;15(4):391-402. doi: 10.1007/s00586-005-1021-4. Epub 2005 Oct 11.

    PubMed 16217665

  • GILL GG, MANNING JG, WHITE HL. Surgical treatment of spondylolisthesis without spine fusion; excision of the loose lamina with decompression of the nerve roots. J Bone Joint Surg Am. 1955 Jun;37-A(3):493-520. No abstract available.

    PubMed 14381447

  • France JC, Yaszemski MJ, Lauerman WC, Cain JE, Glover JM, Lawson KJ, Coe JD, Topper SM. A randomized prospective study of posterolateral lumbar fusion. Outcomes with and without pedicle screw instrumentation. Spine (Phila Pa 1976). 1999 Mar 15;24(6):553-60. doi: 10.1097/00007632-199903150-00010.

    PubMed 10101819

  • Moller H, Hedlund R. Instrumented and noninstrumented posterolateral fusion in adult spondylolisthesis--a prospective randomized study: part 2. Spine (Phila Pa 1976). 2000 Jul 1;25(13):1716-21. doi: 10.1097/00007632-200007010-00017.

    PubMed 10870149

  • Thomsen K, Christensen FB, Eiskjaer SP, Hansen ES, Fruensgaard S, Bunger CE. 1997 Volvo Award winner in clinical studies. The effect of pedicle screw instrumentation on functional outcome and fusion rates in posterolateral lumbar spinal fusion: a prospective, randomized clinical study. Spine (Phila Pa 1976). 1997 Dec 15;22(24):2813-22. doi: 10.1097/00007632-199712150-00004.

    PubMed 9431617

  • McGuire RA, Amundson GM. The use of primary internal fixation in spondylolisthesis. Spine (Phila Pa 1976). 1993 Sep 15;18(12):1662-72. doi: 10.1097/00007632-199309000-00015.

    PubMed 8235847

Questions about this trial

What is this clinical trial studying?

An observational study of Spine Fusion and Isthmic Spondylolisthesis, run by Aesculap AG at 3 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Recruitment too slow). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Leg pain (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03507881, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.

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